Clinical Study About Blood Pressure Measurement Efficacy on Multifunction Keito
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 16, 2011 | ||||||||
| Last Updated Date | May 24, 2011 | ||||||||
| Start Date ICMJE | March 2011 | ||||||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Operator measurements using the Same Arm sequential method as indicated on [5.2.4.2] of the Standard applied. [ Time Frame: Two weeks ] [ Designated as safety issue: No ] Each patient has to be measured by the reference auscultatory sphygmomanometer three times by the two different observers using a double stethoscope. The observers have accorded to use the K5 korotkoff Sound. Between each measurement, the patient has been relaxed at least 60 sec. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01359748 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Multifunction Keito BP measurement.[5.2.4.2] of the standard applied [ Time Frame: Two Weeks. ] [ Designated as safety issue: No ] The patient has been measured three times by the device under test. Between each measurement, the patient has been relaxed at least 60 sec. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Clinical Study About Blood Pressure Measurement Efficacy on Multifunction Keito | ||||||||
| Official Title ICMJE | Clinical Study About Blood Pressure Measurement Efficacy on Multifunction Keito | ||||||||
| Brief Summary | The purpose of this trial is to determine the accuracy of the BP measurement of multifunction Keito devices under test requirements of the Standard ANSI/AAMI/ISO 81060-2:2009. |
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| Detailed Description | Nowadays is important controlling our basic health parameters. Due this, the multifunction Keito Devices was designed to offer to the general public a convenient way to do soeasily in the public sites. One of the most important parameter is the BP measurement. To warrant their efficacity and accuracity, was essential to perform this trial to ensure that the measurements obtained meet with the requirements of the specific U.S. standard about Non-invasive sphygmomanometers. By Validating with auscultatory reference sphygmomanometer, as defined on the ANSI/AAMI/ISO 81060-2:2009 , we have been intending to demonstrate that the multifunction Keito devices, particulary about the BP Measurement, have the same efficacy and accuracy as the conventional auscultatory sphygmomanometers. To include most of the groups of BP measurements types on this clinical trial, a great variety of BP ranges have been selected, always in accordance with the standard. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | The population has been selected and defined prior by their wrist size. Once all the measures have been performed, they were clasified according to their sistolic and diastolic measures ranges, following the standard requirements. |
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| Condition ICMJE | The Focus of Study is to Determine Efficiency and Accuracy of the Multifunction Keito Under the ANSI/AAMI/ISO 81060-2:2009. | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 89 | ||||||||
| Completion Date | March 2011 | ||||||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 83 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Not Provided | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01359748 | ||||||||
| Other Study ID Numbers ICMJE | K8-BP-31032011 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Angel Pons Ferre / Technical Head, Aguiflai Iberica, s.l | ||||||||
| Study Sponsor ICMJE | Aguiflai Iberica, S.L. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Aguiflai Iberica, S.L. | ||||||||
| Verification Date | May 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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